- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01962688
Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment
A Randomized Study of Pocket Ultrasound Derived IVC Diameter for Guided Management of Heart Failure
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
The purpose of this research study is to investigate the use of pocket ultrasound device, called Vscan, in guiding diuretic therapy in ambulatory and inpatient Congestive Heart Failure (CHF) patients. Specifically, Vscan will be used to monitor Inferior Vena Cava (IVC) diameters with the goal of reaching a 50% reduction in IVC when compared to baseline measurements. We hypothesize that compared to the conventional clinical assessment Guided Diuretic Therapy, this new proposed Vscan guided therapy will result in reduction in hospitalization rates. This study is composed of two independent non-interacting randomized single blinded trials-one in the outpatient setting and one in the inpatient setting. 138 total patients and 300 patients will be recruited to the ambulatory trial and inpatient trial respectively.
- Objectives The objective of the study is to determine whether a simple one step protocol of increasing diuretics to guide a 50% reduction of IVC diameter from baseline measurements results in reduction in hospitalization rates as compared to those seen in therapy determined on the basis of conventional clinical evaluation by a CHF specialist.
- Background Congestive heart failure (CHF) remains a leading cause of death in industrialized countries. Despite advances in medical treatment, an estimated 250,000-300,000 CHF patients are hospitalized in the United States each year for symptoms caused by low cardiac output (CO). Although the events that cause acute decompensation are multifactorial, the common pathway associated with decreased ventricular function are autonomic dysfunction and fluid retention. It has been previously suggested that an estimated 50%-66% of CHF hospitalizations may be preventable with improved monitoring of fluid volume status. The size and shape of the inferior vena cava (IVC) is correlated to the central venous pressure and circulating blood volume. Therefore evaluation of the IVC provides an instantaneous non-invasive measure of volume status.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
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New York
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New York, New York, Egyesült Államok, 10029
- Icahn School of Medicine at Mount Sinai
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Patients with a diagnosis of congestive heart failure
- NYHA class II-IV (ambulatory only)
- left ventricular systolic dysfunction with ejection fraction (EF) < 50%
- history of hospitalization for heart failure within the last year (ambulatory only)
- age >18 years old
- admission to heart failure service (inpatient arm only)
Exclusion Criteria:
- Patients with dyspnea not mainly due to heart failure
- valvular disease requiring surgery
- acute coronary syndromes within the previous 10 days
- revascularization within the previous month
- body mass index higher than 35
- serum creatinine level higher than 2.49 mg/dL
- a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only)
- a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
- non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only)
- unable to give informed consent
- no follow-up possible
- participating in another study
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: Handheld ultrasound - inpatient
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy
|
Handheld ultrasound determination of IVC diameter
Más nevek:
|
Sham Comparator: Sham ultrasound - inpatient
Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study.
These patients receive a sham ultrasound to facilitate blinding
|
sham ultrasound to facilitate blinding
Más nevek:
|
Kísérleti: Handheld ultrasound - ambulatory
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy in the ambulatory setting during normal clinic visits.
|
Handheld ultrasound determination of IVC diameter
Más nevek:
|
Sham Comparator: Sham ultrasound - ambulatory
Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study.
These patients receive a sham ultrasound to facilitate blinding in the ambulatory setting during normal clinic visits.
|
sham ultrasound to facilitate blinding
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Participants Hospitalized for Cardiovascular Reasons
Időkeret: up to 6 months
|
hospitalization information will be recorded throughout the length of the study for the outpatient arms
|
up to 6 months
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Number of Participants Hospitalized for Non-cardiac Reasons
Időkeret: up to 6 months
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hospitalization information will be recorded throughout the length of the study for the inpatient arms
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up to 6 months
|
Diuretic Change Post-visit
Időkeret: 6 months followup
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Differences in Changes made in Diuretic doses after Heart failure related visit
|
6 months followup
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Participants in Each New York Heart Association Class
Időkeret: 6 months
|
New York Heart Association (NYHA) Classification Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
6 months
|
Change in Health Related Quality of Life
Időkeret: 1 month and 6 months
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Change in Health related quality of life at 6 months as compared to at 1 month
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1 month and 6 months
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Length of Stay
Időkeret: up to 6 months
|
length of stay in the hospital for inpatient arms only
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up to 6 months
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai
Publikációk és hasznos linkek
Általános kiadványok
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- O'Connor CM, Abraham WT, Albert NM, Clare R, Gattis Stough W, Gheorghiade M, Greenberg BH, Yancy CW, Young JB, Fonarow GC. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008 Oct;156(4):662-73. doi: 10.1016/j.ahj.2008.04.030.
- Blehar DJ, Dickman E, Gaspari R. Identification of congestive heart failure via respiratory variation of inferior vena cava diameter. Am J Emerg Med. 2009 Jan;27(1):71-75. doi: 10.1016/j.ajem.2008.01.002.
- McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c.
- Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.
- Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.
- Moreno FL, Hagan AD, Holmen JR, Pryor TA, Strickland RD, Castle CH. Evaluation of size and dynamics of the inferior vena cava as an index of right-sided cardiac function. Am J Cardiol. 1984 Feb 1;53(4):579-85. doi: 10.1016/0002-9149(84)90034-1.
- Gheorghiade M, Filippatos G, De Luca L, Burnett J. Congestion in acute heart failure syndromes: an essential target of evaluation and treatment. Am J Med. 2006 Dec;119(12 Suppl 1):S3-S10. doi: 10.1016/j.amjmed.2006.09.011.
- Drazner MH, Hellkamp AS, Leier CV, Shah MR, Miller LW, Russell SD, Young JB, Califf RM, Nohria A. Value of clinician assessment of hemodynamics in advanced heart failure: the ESCAPE trial. Circ Heart Fail. 2008 Sep;1(3):170-7. doi: 10.1161/CIRCHEARTFAILURE.108.769778.
- Blair JE, Brennan JM, Goonewardena SN, Shah D, Vasaiwala S, Spencer KT. Usefulness of hand-carried ultrasound to predict elevated left ventricular filling pressure. Am J Cardiol. 2009 Jan 15;103(2):246-7. doi: 10.1016/j.amjcard.2008.08.061. Epub 2008 Oct 30.
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- Goonewardena SN, Blair JE, Manuchehry A, Brennan JM, Keller M, Reeves R, Price A, Spencer KT, Puthumana J, Gheorghiade M. Use of hand carried ultrasound, B-type natriuretic peptide, and clinical assessment in identifying abnormal left ventricular filling pressures in patients referred for right heart catheterization. J Card Fail. 2010 Jan;16(1):69-75. doi: 10.1016/j.cardfail.2009.08.004. Epub 2009 Sep 26.
- Patel AR, Alsheikh-Ali AA, Mukherjee J, Evangelista A, Quraini D, Ordway LJ, Kuvin JT, Denofrio D, Pandian NG. 3D echocardiography to evaluate right atrial pressure in acutely decompensated heart failure correlation with invasive hemodynamics. JACC Cardiovasc Imaging. 2011 Sep;4(9):938-45. doi: 10.1016/j.jcmg.2011.05.006.
- Hollerbach S, Schultze K, Muscholl M, Scholmerich J. [Ultrasonography of the inferior vena cava (IVC) in the diagnosis and monitoring of therapy in patients with chronic congestive heart failure]. Dtsch Med Wochenschr. 2001 Feb 9;126(6):129-33. doi: 10.1055/s-2001-11047. German.
- Guiotto G, Masarone M, Paladino F, Ruggiero E, Scott S, Verde S, Schiraldi F. Inferior vena cava collapsibility to guide fluid removal in slow continuous ultrafiltration: a pilot study. Intensive Care Med. 2010 Apr;36(4):692-6. doi: 10.1007/s00134-009-1745-4. Epub 2010 Jan 22.
- Gackowski A, Isnard R, Golmard JL, Pousset F, Carayon A, Montalescot G, Hulot JS, Thomas D, Piwowarska W, Komajda M. Comparison of echocardiography and plasma B-type natriuretic peptide for monitoring the response to treatment in acute heart failure. Eur Heart J. 2004 Oct;25(20):1788-96. doi: 10.1016/j.ehj.2004.07.038.
- Miller JB, Sen A, Strote SR, Hegg AJ, Farris S, Brackney A, Amponsah D, Mossallam U. Inferior vena cava assessment in the bedside diagnosis of acute heart failure. Am J Emerg Med. 2012 Jun;30(5):778-83. doi: 10.1016/j.ajem.2011.04.008. Epub 2011 Jun 12.
- Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Kirkpatrick JN, Spencer KT. Reappraisal of the use of inferior vena cava for estimating right atrial pressure. J Am Soc Echocardiogr. 2007 Jul;20(7):857-61. doi: 10.1016/j.echo.2007.01.005.
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Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- GCO 13-0324
- IF1486768 (Egyéb azonosító: Mount Sinai)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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